Study Screening Details

Study Design Details

Rating

Design

Attrition

Baseline Equivalence

Reassignment

Confounding Factors

Moderate

Randomized Controlled Trial

High

Established on race/ethnicity and SES

None

None

Study Characteristics

Study Participants

The authors used a cluster-randomized trial to test the effects of Minding the Baby®. First-time mothers who attended group prenatal care sessions at the Fair Haven Community Health Center were recruited to participate; all participants who met inclusion criteria were invited into the study and assigned to the condition to which their prenatal group had been randomly assigned. Inclusion criteria for the mother were (a) English oral and comprehension fluency; (b) 14 to 25 years of age; (c) having a first child; (d) no active heroin or cocaine use (already a criteria for participating in group prenatal care); (e) no diagnoses of a psychotic disorder, according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition; and (f) no major or terminal chronic condition (AIDS, cancer, and so on; already an eligibility criteria for group prenatal care participation).

One-hundred and thirty-nine families met criteria and were assigned to the program or control group based on the random assignment status of their prenatal care group (72 treatment and 67 control). Among eligible mothers, 30 declined the invitation to participate (9 treatment and 21 control). After some additional attrition, 60 (treatment) and 45 (control) mothers participated in data collection at baseline. However, the authors also note further attrition at later data collection points; 44 treatment group mothers completed 12- and 24-month data collection, and approximately 34 and 31 control group mothers, respectively, completed data collection at these time points. Mothers were followed for approximately 27 months in total, including the time before the child's birth. Overall, the study sample of mothers was 28 percent black, 62 percent Latina, and 10 percent of another race/ethnicity.

Setting

New Haven, Connecticut

Home Visiting Services

Home visitor teams conducted home visits to enhance parental reflective functioning and the development of secure attachment of the infant. Home visitors conducted a prenatal assessment of the mothers’ reflective functioning capacity. The home visitors also addressed maternal physical and mental health as well as infant mental health clinical care. Home visiting began in pregnancy and occurred weekly until the child’s first birthday, and then biweekly until the child’s second birthday.

Comparison Condition

Mothers in the control group received routine health care (prenatal visits, well-woman care, and well-baby care) as dictated by clinical guidelines. Families also received monthly information sheets about child rearing and health, and birthday and holiday cards.

Staff Characteristics and Training

Home visiting teams consisted of a pediatric nurse practitioner and a clinical social worker.

Funding Source

National Institutes of Health, the Irving B. Harris Foundation, the FAR Fund, the Annie E. Casey Foundation, the Pritzker Early Childhood Foundation, the Seedlings Foundation, the Edlow Family, and the Schneider Family